Hypoparathyroidism
Conditions
Brief summary
(MT)-Efficacy: After 24 weeks of treatment, the proportion of patients in the eneboparatide treatment group vs. placebo: •Achieving complete independence from active vitamin D; •Achieving independence from therapeutic doses of oral calcium (i.e., taking oral elemental calcium supplements ≤600 mg/day); and •With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL).
Detailed description
(MT)-Key secondary efficacy endpoint 1 - At week 24, the proportion of patients in the eneboparatide treatment group vs. placebo who had hypercalciuria at baseline and normalize their 24 hour urinary calcium excretion level (i.e. achieve <250 mg/24 hours for females or <300 mg/24 hours for males);, (MT)-Key secondary efficacy endpoint 2 - At week 24, change from baseline in patient’s symptoms, as assessed by the average weekly HPT DD-SE core physical symptoms scale in the eneboparatide treatment group vs. placebo;, (MT)-Key secondary efficacy endpoint 3 - At week 24, change from baseline in the HPT-LIQ Physical Functioning domain score, in the eneboparatide treatment group vs. placebo;, (MT)-Key secondary efficacy endpoint 4 - At week 24, change from baseline in the SF-36 Physical Functioning subscore in the eneboparatide treatment group vs. placebo., (MT)-Additional secondary endpoint at Week 24: The proportion of patients meeting each component during the fixed dose period: o Independence from active vitamin D; o Independence from therapeutic doses of oral calcium (i.e. taking oral elemental calcium supplements ≤600 mg/day); o Albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL)., (MT)-Additional secondary endpoint: Change from baseline in urinary calcium (24-hour collection) at Week 24, (MT)-Additional secondary endpoint: Change from baseline in urinary calcium (24-hour collection) at Week 24 for patients who had hypercalciuria at baseline
Interventions
DRUGROCALTROL 0
DRUG25 microgramme
DRUGcapsule molle
DRUGPlacebo for AZP-3601 Pen A and Pen B
DRUGUN-ALFA 0
DRUG50 microgramme
DRUGcomprimé à sucer
DRUGAZP-3601
Sponsors
Amolyt Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (MT)-Efficacy: After 24 weeks of treatment, the proportion of patients in the eneboparatide treatment group vs. placebo: •Achieving complete independence from active vitamin D; •Achieving independence from therapeutic doses of oral calcium (i.e., taking oral elemental calcium supplements ≤600 mg/day); and •With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL). | — |
Secondary
| Measure | Time frame |
|---|---|
| (MT)-Key secondary efficacy endpoint 1 - At week 24, the proportion of patients in the eneboparatide treatment group vs. placebo who had hypercalciuria at baseline and normalize their 24 hour urinary calcium excretion level (i.e. achieve <250 mg/24 hours for females or <300 mg/24 hours for males);, (MT)-Key secondary efficacy endpoint 2 - At week 24, change from baseline in patient’s symptoms, as assessed by the average weekly HPT DD-SE core physical symptoms scale in the eneboparatide treatment group vs. placebo;, (MT)-Key secondary efficacy endpoint 3 - At week 24, change from baseline in the HPT-LIQ Physical Functioning domain score, in the eneboparatide treatment group vs. placebo;, (MT)-Key secondary efficacy endpoint 4 - At week 24, change from baseline in the SF-36 Physical Functioning subscore in the eneboparatide treatment group vs. placebo., (MT)-Additional secondary endpoint at Week 24: The proportion of patients meeting each component during the fixed dose period: o Indepe | — |
Countries
Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed